Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include:

  • The study and treatment duration will be up to approximately 5 years.
  • The number of visits will be approximately 38.

Official Title

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

Keywords

Kidney Transplant Rejection, Tacrolimus, Antilymphocyte Serum, Mycophenolic Acid, Methylprednisolone, Prednisone, Frexalimab, rabbit anti-thymocyte globulin, mycophenolate mofetil, mycophenolate sodium

Eligibility

You can join if…

Open to people ages 18-70

  • Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
  • Participants with low to moderate immunological risk.

You CAN'T join if...

  • Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.
  • Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.
  • Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.
  • Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
  • Evidence of active or latent TB, HIV, HBV or HCV infection.
  • Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
  • Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations

  • University of California San Francisco - Parnassus Heights- Site Number : 8400001 accepting new patients
    San Francisco California 94143 United States
  • University of Washington Medical Center- Site Number : 8400035 accepting new patients
    Seattle Washington 98195 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
Links
EFC18554 Plain Language Results Summary For EU sites click here and navigate to 'Locations and contact points'
ID
NCT07412470
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 526 study participants
Last Updated